Many products require particular handling to ensure that the product is safe and/or useable after being transported or stored for a period of time. Food products and medical related products fall into this category. In many cases, there are governmental regulations, such as provided by the Food and Drug Administration (FDA), for the care and handling of certain products.
Blood products are an example of medical related products that require particular handling during transportation and storage. For example, a community blood supplier works with donors, blood centers, and hospitals and other healthcare service providers to provide blood products and services. As part of a blood supplier's responsibilities, blood donations are collected and the donated blood is provided to refrigerated blood lockers in hospitals and other healthcare facilities. The blood supplier is responsible for inventorying and tracking their blood to a blood locker or other storage facility and removing the blood that is old or not usable from the blood locker or other storage facility.
The donated blood supply chain for hospitals and medical emergencies is heavily regulated by the FDA. To prevent problems occurring during transfusion of, or experimentation with, the collected blood, the FDA has established requirements for the handling of blood. For example, blood products are required to be stored in refrigerators with strict temperature control. In addition, blood products are required to be packed and transported in FDA certified containers under controlled conditions.
For example, it is important when transporting blood for later uses or transfusion to maintain equilibrium between glucose, adenosine triphosphate (ATP), and pH levels. All three of these components are temperature dependent. One concern with blood transportation is the growth of bacteria, which would contaminate the blood. At temperatures higher than 6° C., it is assumed that bacteria would be able to grow to such an extent as to deem the blood contaminated. In addition, higher temperatures can increase the rate of natural senescence of the red blood cells. Another concern is preventing hemolysis. When red blood cells start to freeze (below 2° C.), the cells' membranes start to rupture allowing the hemoglobin to be released out of the cells. Therefore, whole blood and red blood cells are suggested to be stored between 2° C. and 6° C. Other blood related products such as plasma and cryoprecipitate are required to be frozen for storage. For example, plasma is recommended to be stored at −30° C. and must always stay a frozen solid in order to be considered usable.
During transportation or in readying for use, blood products may be exposed to higher than recommended and sometimes lower than recommended temperatures. FDA regulations indicate that when transporting pre-processed blood, the temperature cannot be allowed to be at a temperature in the range of 20° C.-24° C. for more than six hours.
The precise temperature ranges are crucial to maintain in an effort to diminish risks from using contaminated or mishandled blood. However, the temperature information is not available in the transported blood bag containers, when the blood is taken from refrigeration, or when the blood is awaiting use in an operating room during surgeries. Instead, temperature information is known only at a large scale level, such as a refrigerator with hundreds of blood bags. This lack of information at the blood bag level results in blood (at the individual blood bag level) being discarded when the blood bag's temperature handling and history is questionable. Similar issues arise and waste may occur for other products (such as other medical products, food products, and sensitive/perishable materials) as well.